Monday, November 05, 2012

Getting Back to Work

We’re getting back to work.At times it’s hard, particularly with no power.It’s amazing how much we rely on electricity and miss it when it’s gone.

But the storm brought a few good things.One was dinner at the mayor’s house (the mayor had power).Yeah, it’s a small town of 2,000, but it still felt good to dine with the mayor.Another was experiencing so many from our town gathering at the downtown coffee shop to talk, feel some heat, charge up, and have hot food and drink.

But mostly the storm was just bad.Towns and communities along the ocean were decimated –Long Island, Queens, Brooklyn, Staten Island, and many towns along the Hudson River.For those of us who grew up in or near New Jersey, the worst thing may be what happened to the Jersey Shore.That place – from Sandy Hook all the way down to Cape May – is part of our happy-times DNA, a place with so many unshakeable memories: Ferris Wheel rides over the sand; water slides and roller coasters (for kids and older); pizza and games on the boardwalk; body surfing the Atlantic Ocean waves by day and hearing them crash while at a bonfire at night; great music at the night clubs; the first bar you snuck into underage (well, some of us); or maybe seeing Bruce Springsteen just show up at a small bar and play with the house band.

So it’s emotional to watch the videos of what’s left and what’s not.(Page forward on this news page for the video titled “Chopper 12: Jersey Shore storm damage” to see some of what we’re talking about.)If you have an opportunity and the means and haven’t already, check in with the Red Cross and give what you can.There are so many families with real problems, not just power outages, and a lot to rebuild.

But it’s back to work, so here’s an excellent Mensing preemption decision – Purvis v. Teva Pharmas., USA, Inc., 2012 WL 5364392 (M.D. La. Oct. 30, 2012).The plaintiff used generic metoclopramide, experienced side effects and sued the generic manufacturers under theories of failure to warn, warranty and design defect.One of the manufacturers moved for judgment on the pleadings and got it.

Dismissing the failure to warn claim was easy for the court, which gave a spot-on explanation of impossibility preemption:

[A]n implied conflict exists where it is “impossible for a private party to comply with both state and federal requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S. Ct. 1483, 131 L Ed.2d 385 (1995).

Here, the Court finds impossibility on the part of Defendant. Defendant Generics was unable to satisfy their state-law duty to change the warnings of their generic drug while simultaneously complying with federal requirements. Under Louisiana law, “when the danger is known to the manufacturer and cannot justifiably be expected to be within the knowledge of users generally, the manufacturer must take reasonable steps to warn the user.” Chappuis v. Sears, Roebuck & Co., 358 So.2d 926, 930 (La.1978); see also La. Rev. Stat. Ann. § 9:2800.57 (2009). In contrast, federal drug regulations, as interpreted by the FDA, prevent manufacturers from “independently changing their generic drugs' safety labels.” Mensing, 131 S. Ct. at 2577. Furthermore, generic drug manufacturers have an ongoing federal duty of “sameness” with brand-name drugs. Id at 2572.

In this case, if the Defendant had independently changed its labels to satisfy their state-law duty, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Thus, it was impossible for them to comply with both state and federal law. Therefore, state law was preempted.

Id. at *3.

The court was having none of plaintiff’s argument that his failure to warn claim could be based on the defendant’s failure to communicate extra-label information to healthcare providers via means other than the label – for example, via Dear Doctor Letters:

Plaintiff identified numerous other communication tools that, according to Plaintiff, drug manufacturers can and should take to minimize an identified risk. As previously noted, the Supreme Court in Mensing held that the issuance of warnings via communications to health care professionals cannot be contrary to the drug's approved labeling. Moreover, the Court in Mensing described that the issuance of warnings by generic brands alone could imply a therapeutic difference between the generic brand and name-brand drugs. Thus, Plaintiff's failure to warn claim is preempted by Federal drug regulations.

Id. at 4 (citations omitted).

The court also saw through plaintiff’s warranty and design defect claims, noting that he really “only alleged facts which challenge the adequacy of Defendant’s warnings.”Id. at *4.There were no facts to support a warranty claim: “Plaintiffs does not allege that Defendants made any advertisements or other forms of communications regarding its products beyond the package insert.”Id.And there was nothing to support a design defect claim:

Plaintiff has not provided factual content to support his design defect claim and has failed to make sufficient arguments for this claim in his briefs.FN3 Plaintiff merely makes a formulaic recitation of the statutory provisions and conclusory allegations. Plaintiff has not alleged that there existed an alternative design for the drug which is an essential element of a LPLA design defect claim. Further, Plaintiff has not alleged that the burden on the manufacturer to develop such a drug outweighed the dangers posed by the current design. Because Plaintiff has not alleged sufficient factual content and argument regarding his other LPLA claims, all such claims must be dismissed.

Id.We’ll note that the “FN3” you see in this block quote references a footnote in which the court rejects plaintiff’s request that it follow the Bartlett decision, which we’ve questioned before on this blog.Nice, and certainly a good decision to return to work to.

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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